Since 2017, cannabis in Germany has been able to use medical purposes. Now a clinical study with more than 800 participants shows that an extract from this hemp plant can help against chronic back pain. Anyone who received the substance called 001 reported more pain relief than subjects from the placebo group. There were usually only slight side effects and no signs of dependency. The manufacturer has applied for approval for the fund.
Worldwide, more than half a billion people suffer from chronic back pain. If non-drug approaches such as movement and stress reduction do not help sufficiently, pain relievers often use, in severe cases, opioids. However, these have significant side effects and can make it dependent. Lighter pain relievers such as ibuprofen, on the other hand, often cannot reduce the pain sufficiently and also burden the gastrointestinal tract, the cardiovascular system and kidney and liver when taking it for a long time.
New treatment option?
“The current pharmacological treatments are only effective and mount considerable risks, which makes the development of safe and effective alternatives necessary,” explains a team around Matthias Karst from the Hannover Medical School. Karst and his colleagues have now successfully tested such an alternative in a clinical phase 3 study. According to this, an extract from cannabis called Verver verses relieves chronic back pain better than a placebo preparation. 820 adults with chronic back pain took part in the study, who had so far insufficiently helped non-opioid medication. One group received VER001, another one placebo, whereby neither the patients nor their doctors knew who received which treatment.
At the beginning of the study, the pain intensity of the participants on a scale from one to ten average was six. After twelve weeks, the patients from the Ver01 group reported that their pain on the scale had decreased by an average of 1.9 points. In the placebo group, too, the pain intensity had significantly reduced to an average of 1.4 points-a typical phenomenon, since expectations can only be provided. The difference of 0.5 points, on the other hand, is probably due to the effect of the drug, as the team explains.
Less pain and better sleep
Treatment with the cannabis extract had other positive effects: the patients who had received this medicine reported that their sleep quality improved significantly and they felt more physically more physically. On the other hand, Verben had no exhilarating effects. Although the preparation also contains the psychoactive substance THC, this is so low at 2.5 mg per dose that it does not explain high as Karst and his colleagues. In addition, the researchers did not observe any signs of dependency on their test subjects. After the twelve-week, all subjects were given for six more months. Then some of the participants were switched to placebo. As a result, their pain increased again, but withdrawal symptoms were not shown.
However, the cannabis drug also has side effects, including dizziness, tiredness and nausea, especially at the beginning of treatment. Although these effects were usually only slightly to moderate, 68 people (17.4 percent) break down from the Ver01 group due to side effects. In the placebo group there were only 15 people (3.5 percent).
Appreciated approval
Nevertheless, Karst and his team see clear indications of a well-effective and relatively compatible pain relief in their results: “Our study provides solid evidence of the effectiveness and security of Verter in the treatment of chronic back pain,” summarize the researchers. “These results underline the importance of further research with other chronic pain conditions and indicate that Verter could play an important role in modern pain treatment.” Approval for the drug has already been requested.
Ulrike Bingel, who heads pain medicine at the University Hospital Essen and was not involved in the study, critically points out that the difference between treatment and placebo group of only 0.5 points on the pain scale is statistically significant, but is not necessarily clinically relevant. In their view, the therapy could possibly be more helpful for certain patient groups than for others. “The first signals from the study already point out that patients with a larger neuropathic pain component may benefit better from the substance,” she explains.
However, if you currently suffer from chronic back pain, you should not be tempted to try self -therapy with cannabis. This is pointed out by Jan Vollert from the University of Exeter, who was also not involved in the study. “Ver01 is a very specific substance that is handed over in a controlled manner. It is in no way comparable to smoking cannabis,” he explains.
Source: Matthias Karst (Hannover Medical School) et al., Nature Medicine, DOI: 10.1038/S41591-025-03977-0